An observational study in Type2 Diabetes Mellitus and Complications, sponsored by University of Algiers. Completed at 1 site in Algeria. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-06-21.
Sponsored by University of Algiers · Observational
To reach the two purposes, we need to conduct a cohort study:
For the secondary purpose, the cohort population is followed up for one year, the patients are treated commonly. We'll check out all the cardiovascular events linked to atherothrombosis.Two groups of patients might be formed:
We will compare the two groups, on occurence of cardiovascular events, after adjustment of age and major cardiovascular risk factors, and after excluding patients 'not exposed' having had a prior treatment with conversion enzyme inhibitor or angiotensin receptor antagonist .
The size of the sample is calculated with statistical formula:
n= E2 Po Qo / i2 n= size of the sample E= 1.96 with error risk : alpha= 5% Po= 30% Qo= 1-Po "n" is at least egal to 323 patients
Statistical analysis is performed with epi info 6.04b and all tests are performed with an error risk alpha= 5%
Descriptive statistics of patients characteristics:
Comparative statistics according to existence of renal disease or not
Population of type 2 diabetes patients that diabetes is diagnosed recently, in one of the health structures, in the east suburban area of Algiers. In the first step they are recruited by primary care physicians, on the basis of glycemia >= 1.26 g/l (capillary or venous); then they are automatically directed to the main investigator, in hospital consultation, to confirm by two blood samples, the hyperglycemia; and (second step) screen for differential diagnosis (secondary diabetes)before the definitive recruitment.Patients are systematically,consecutively recruited. They are followed up during 1 year, they are seen every 3months at least.
Exclusion Criteria:
After screening for complications, a non specific multi interventional treatment is applied to patients. After one year of follow up, we will compare two groups: with and without chronic kidney disease, on the advent of cardiovascular events. An adjustment is done for age and major risk factors.
Other: no specific treatment
lifestyle counseling, antihypertensive drugs, antidiabetic drugs (oral and / or insulin)treatment of comorbidity or complications of diabetes.
Number and Prevalence of Patients With Diabetic Retinopathy
* Conventional ophtalmoscopy has been used to screen for diabetic retinopathy by an ophtalmologist at his office. * Retinal angiography was performed if indicated by the ophtalmologist
Time frame: At recruitment
Number of Patients With Distal Diabetic Neuropathy
All 327 patients had a neurological examination by the same physician to screen for Distal Diabetic Neuropathy: * Distal sensory testing: including 10 g monofilament test, vibration perception with 128 Hz tuning fork, temperature, touch , prickling and pain perception * Ankles and knees reflex testing * Muscle strength testing (quadriceps and tibialis anterior) * We use the Michigan Neuropathy Screening Instrument score. We consider the diagnosis of Distal Diabetic Neuropathy if the score is up of 2 in at least one food. The MNSI score is ranged from 0 to 5 for each food * Use of neuropathic pain score (DN4), if the DN4 is found up or egal to 4 we consider the diagnosis of neuropathic pain. The DN4 score is ranged from 0 to 10
Time frame: At recruitment
Number of Patients With Chronic Kidney Disease (CKD)
* We screened for albuminuria or microalbuminuria in 24h urine collection with turbidimetry or immuno turbidimetry method ( performed 3 times in 4 or 6 months ) * Measurement of albumine- to- creatinine ratio (ACR), Albuminuria was diagnosed if ACR \> or egal to 30 mg/g at least twice in 4 to 6 months. We ensure before performing ACR that there was no dysglycaemia, no urinary infection, no fever nor forced diuresis before we evaluate the urine sample. * Cyto bacteriological examination and urine culture * Serum creatinine repeated 2 to 3 time within 4 to 6 months * Glomerular filtration rate was assessed with the Modification of Diet in Renal disease study equation (MDRD) * Renal and urine tract echography to measure the kidneys and to screen for urine tract dilatation We made the diagnosis of Chronic Kidney Disease (CKD) if the glomerular filtration rate was \< 60 ml/min/1.73 m² and/or ACR \> or equal to 30 mg/g with a permanent character
Time frame: At recruitment
Number of Patients With Hypertension
* Blood pressure measurement by electronic tensiometer (OMRON 3 or 4) on the right and left arm, after 10 mn of supine position. * Three measures were performed with respect of one minute interval between each measure. * Mean blood pressure is calculated * Three other measures are performed in Three ulterior consultations * Hypertension is diagnosed if the mean blood pressure \>= 140 /90 mm Hg
Time frame: At recruitment
Number of Patients With Silent Myocardial Ischemia
* 9 derivations resting electrocardiogram (ECG) * Echocardiography * Standard ECG stress test * Stress Myocardial Perfusion scintigraphy if patients are not able to perform ECG stress test * Coronary angiography if the exercise ECG stress test or stress myocardial perfusion scintigraphy suggest high probability of coronary heart disease
Time frame: At recruitment
Number of Patients With Lower Extremity Artery Disease
* Search for history of intermittent claudication * Complete vascular examination with Ankle-Brachial Index (ABI) measurement. * Lower limb duplex ultrasonography.
Time frame: At recruitment
Number of Patients With Carotid Artery Stenosis
* Screening for carotid murmur at clinical examination by the same physician for all patients * Carotid duplex ultrasonography with intima-media thickness measurement. All atherosclerotic lesions were reported.
Time frame: At recruitment
Number of Patients With Renal Artery Stenosis or Elevated Intrarenal Resistance Index
- Renal artery duplex ultrasonography has been performed only if the patient presents a resistant hypertension treated with four drugs, including a diuretic or if blood pressure was over 180/10 mm Hg at recruitement.
Time frame: At recruitment
Number of Patients With Cardiac Autonomic Neuropathy
* Conditions of the Ewing tests: fasting, resting at least 30mn, no hypoglycemia and no effort within 24hours, no drugs that interfere with heart rate. * Ewing Tests for cardiac autonomic neuropathy: Beat-to-Beat heart rate variation, Heart rate response to standing, Heart rate response to valsalva maneuver, Systolic blood pressure response to standing. All tests have been performed with the same physician and aid
Time frame: at recruitment
Number of Patients With Bladder Autonomic Neuropathy
* History of recurrent urine tract infection and/or dysuria and/or incomplete bladder emptying * Post voiding residual(PVR) measurement with abdominal echography by a radiologist * Cystomanometry is performed if PVR \> 50 ml * In men the prostatic measurement was made in all patients. In women, we measured the volume of uterus.
Time frame: at recruitment
Number of Patients With Gastro-intestinal Autonomic Neuropathy
* We interviewed all patient, looking for a history of post prandial discomfort or bad gastric emptying sensation or vomiting or unexplained diarrhea or constipation * We performed an endoscopic examination to exclude other causes in patients with a positive history of gastro-intestinal troubles.
Time frame: at recruitment
Number of Patients With Erectile Dysfunction
- Questionary: onset , drug use, medical history, psycho- social conditions
Time frame: at recruitment
Number of Patients With New Cardiac Events During Follow-up
* We Record every documented acute coronary syndrome during follow-up; * Each patient had an electrocardiogram every 3 months and during acute cardiovascular events; * Echocardiography has been performed if indicated by the cardiologist.
Time frame: One year after recruitment
Number of Patients With New Stroke or Transient Ischemic Attack
* We assessed every new clinical signs of stroke with an interview searching for acute neurological symptoms and a clinical examination for all patients, from day one of recruitment to one year of follow-up; * Tomodensitometry if there was a clinical presentation of stroke. Magnetic resonance imaging if transient ischemic attack was suspected.
Time frame: One year after recruitment
Number of Patients With Lower Limbs Atherothrombotic Accident
During one year of follow-up : * We search for a recent history of intermittent claudication; * We perform a systematic clinical examination with palpation of lower limb pulses and an Ankle-Brachial Index measurement after one year or in the presence of an acute ischemic lower limb episod ; * Lower limb duplex sonography in the presence of an abnormal clinical vascular examination; * Angiography in the presence of a lower limbs vascular event.
Time frame: One year after recruitment
Number of Patients That Died From Cardio Vascular Cause
- We recorded each death and its cause from a medical record after hospitalization in emergency units or phone contact with the patient's relatives to have some news. The record began with recruitment.
Time frame: One year after recruitment
327 patients aged from 40 to 70 years were seen from 2009 to 2013. The main investigator confirmed the diagnosis of type 2 diabetes. A secondary diabetes was excluded before definitive recruitment. When the diagnosis of type 2 diabetes is highly probable and ensure that it was newly diagnosed, we screened for all chronic complications.
| Milestone | Complications' Assessment for Men | Complications' Assessment for Women |
|---|---|---|
| Started | 122 | 205 |
| Completed | 109 | 191 |
| Not completed | 13 | 14 |
| Withdrew: Lost to follow-up | 10 | 12 |
| Withdrew: Death | 3 | 2 |
| Milestone | Complications' Assessment for Men | Complications' Assessment for Women |
|---|---|---|
| Started | 109 | 191 |
| Completed | 109 | 191 |
| Not completed | 0 | 0 |
* Conventional ophtalmoscopy has been used to screen for diabetic retinopathy by an ophtalmologist at his office. * Retinal angiography was performed if indicated by the ophtalmologist
| Participants | Men Group | Women Group |
|---|---|---|
| Number and Prevalence of Patients With Diabetic Retinopathy | 9 | 18 |
All 327 patients had a neurological examination by the same physician to screen for Distal Diabetic Neuropathy: * Distal sensory testing: including 10 g monofilament test, vibration perception with 128 Hz tuning fork, temperature, touch , prickling and pain perception * Ankles and knees reflex testing * Muscle strength testing (quadriceps and tibialis anterior) * We use the Michigan Neuropathy Screening Instrument score. We consider the diagnosis of Distal Diabetic Neuropathy if the score is up of 2 in at least one food. The MNSI score is ranged from 0 to 5 for each food * Use of neuropathic pain score (DN4), if the DN4 is found up or egal to 4 we consider the diagnosis of neuropathic pain. The DN4 score is ranged from 0 to 10
| Participants | Men Group | Women Group |
|---|---|---|
| Number of Patients With Distal Diabetic Neuropathy | 42 | 56 |
* We screened for albuminuria or microalbuminuria in 24h urine collection with turbidimetry or immuno turbidimetry method ( performed 3 times in 4 or 6 months ) * Measurement of albumine- to- creatinine ratio (ACR), Albuminuria was diagnosed if ACR \> or egal to 30 mg/g at least twice in 4 to 6 months. We ensure before performing ACR that there was no dysglycaemia, no urinary infection, no fever nor forced diuresis before we evaluate the urine sample. * Cyto bacteriological examination and urine culture * Serum creatinine repeated 2 to 3 time within 4 to 6 months * Glomerular filtration rate was assessed with the Modification of Diet in Renal disease study equation (MDRD) * Renal and urine tract echography to measure the kidneys and to screen for urine tract dilatation We made the diagnosis of Chronic Kidney Disease (CKD) if the glomerular filtration rate was \< 60 ml/min/1.73 m² and/or ACR \> or equal to 30 mg/g with a permanent character
| Participants | Men Group Population | Women Group Population |
|---|---|---|
| Number of Patients With Chronic Kidney Disease (CKD) | 35 | 43 |
* Blood pressure measurement by electronic tensiometer (OMRON 3 or 4) on the right and left arm, after 10 mn of supine position. * Three measures were performed with respect of one minute interval between each measure. * Mean blood pressure is calculated * Three other measures are performed in Three ulterior consultations * Hypertension is diagnosed if the mean blood pressure \>= 140 /90 mm Hg
| Participants | Men Group Population | Women Group Population |
|---|---|---|
| Number of Patients With Hypertension | 82 | 136 |
* 9 derivations resting electrocardiogram (ECG) * Echocardiography * Standard ECG stress test * Stress Myocardial Perfusion scintigraphy if patients are not able to perform ECG stress test * Coronary angiography if the exercise ECG stress test or stress myocardial perfusion scintigraphy suggest high probability of coronary heart disease
| Participants | Men Group Population | Women Group Population |
|---|---|---|
| Number of Patients With Silent Myocardial Ischemia | 11 | 4 |
* Search for history of intermittent claudication * Complete vascular examination with Ankle-Brachial Index (ABI) measurement. * Lower limb duplex ultrasonography.
| Participants | Men Group Population | Women Group Population |
|---|---|---|
| Number of Patients With Lower Extremity Artery Disease | 6 | 12 |
* Screening for carotid murmur at clinical examination by the same physician for all patients * Carotid duplex ultrasonography with intima-media thickness measurement. All atherosclerotic lesions were reported.
| Participants | Men Group Population | Women Group Population |
|---|---|---|
| Number of Patients With Carotid Artery Stenosis | 7 | 3 |
- Renal artery duplex ultrasonography has been performed only if the patient presents a resistant hypertension treated with four drugs, including a diuretic or if blood pressure was over 180/10 mm Hg at recruitement.
| Participants | Men Group Population | Women Group Population |
|---|---|---|
| Number of Patients With Renal Artery Stenosis or Elevated Intrarenal Resistance Index | 2 | 2 |
* Conditions of the Ewing tests: fasting, resting at least 30mn, no hypoglycemia and no effort within 24hours, no drugs that interfere with heart rate. * Ewing Tests for cardiac autonomic neuropathy: Beat-to-Beat heart rate variation, Heart rate response to standing, Heart rate response to valsalva maneuver, Systolic blood pressure response to standing. All tests have been performed with the same physician and aid
| Participants | Men Group Population | Women Group Population |
|---|---|---|
| Number of Patients With Cardiac Autonomic Neuropathy | 10 | 19 |
* History of recurrent urine tract infection and/or dysuria and/or incomplete bladder emptying * Post voiding residual(PVR) measurement with abdominal echography by a radiologist * Cystomanometry is performed if PVR \> 50 ml * In men the prostatic measurement was made in all patients. In women, we measured the volume of uterus.
| Participants | Men Group Population | Women Group Population |
|---|---|---|
| Number of Patients With Bladder Autonomic Neuropathy | 5 | 11 |
* We interviewed all patient, looking for a history of post prandial discomfort or bad gastric emptying sensation or vomiting or unexplained diarrhea or constipation * We performed an endoscopic examination to exclude other causes in patients with a positive history of gastro-intestinal troubles.
| Participants | Men's Group Population | Women Group Population |
|---|---|---|
| Number of Patients With Gastro-intestinal Autonomic Neuropathy | 0 | 6 |
- Questionary: onset , drug use, medical history, psycho- social conditions
| Participants | Men Group Population |
|---|---|
| Number of Patients With Erectile Dysfunction | 63 |
* We Record every documented acute coronary syndrome during follow-up; * Each patient had an electrocardiogram every 3 months and during acute cardiovascular events; * Echocardiography has been performed if indicated by the cardiologist.
| Participants | Men Group Population | Women Group Population |
|---|---|---|
| Number of Patients With New Cardiac Events During Follow-up | 7 | 2 |
* We assessed every new clinical signs of stroke with an interview searching for acute neurological symptoms and a clinical examination for all patients, from day one of recruitment to one year of follow-up; * Tomodensitometry if there was a clinical presentation of stroke. Magnetic resonance imaging if transient ischemic attack was suspected.
| Participants | Men Group Population | Women Group Population |
|---|---|---|
| Number of Patients With New Stroke or Transient Ischemic Attack | 1 | 2 |
During one year of follow-up : * We search for a recent history of intermittent claudication; * We perform a systematic clinical examination with palpation of lower limb pulses and an Ankle-Brachial Index measurement after one year or in the presence of an acute ischemic lower limb episod ; * Lower limb duplex sonography in the presence of an abnormal clinical vascular examination; * Angiography in the presence of a lower limbs vascular event.
| Participants | Men Group Population | Women Group Population |
|---|---|---|
| Number of Patients With Lower Limbs Atherothrombotic Accident | 0 | 1 |
- We recorded each death and its cause from a medical record after hospitalization in emergency units or phone contact with the patient's relatives to have some news. The record began with recruitment.
| Participants | Men Group Population | Women Group Population |
|---|---|---|
| Number of Patients That Died From Cardio Vascular Cause | 3 | 2 |
Collected over One year after, adverse events were collected. We mean by adverse events all events, that disrupted during one year of follow-up, related to a non-specific treatment or to any pathological state or related or not to diabetic complications.. Non-serious events are listed at a 0.016% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Men's Group | 4/112 (3.6%) | 3/109 (2.8%) | 18/109 (16.5%) |
| Women's Group | 4/193 (2.1%) | 4/191 (2.1%) | 29/191 (15.2%) |
| Event | Men's Group | Women's Group |
|---|---|---|
| Atherothrombotic eventVascular disorders | 3/109 | 4/191 |
| Event | Men's Group | Women's Group |
|---|---|---|
| New onset of permanent hypertensionVascular disorders | 15/109 | 25/191 |
| Moderate acute renal insufficiencyRenal and urinary disorders | 3/109 | 4/191 |
We described gender, age, history of familial, major cardiovascular risk factors and mean anthropometric, blood pressure and biological measures
| Age, Continuous(years) | Men Population | Women Population | Total |
|---|---|---|---|
| Mean | 53.4 ± 8.9 | 53.7 ± 8.4 | 53.5 ± 8.6 |
| Sex: Female, Male(Participants) | Men Population | Women Population | Total |
|---|---|---|---|
| Female | 0 | 205 | 205 |
| Male | 122 | 0 | 122 |
| Region of Enrollment(participants) | Men Population | Women Population | Total |
|---|---|---|---|
| Algeria | 122 | 205 | 327 |
| history of family diabetes(participants) | Men Population | Women Population | Total |
|---|---|---|---|
| Number | 84 | 138 | 222 |
| history of family hypertension(participants) | Men Population | Women Population | Total |
|---|---|---|---|
| Number | 69 | 133 | 202 |
| waist circumference(cm) | Men Population | Women Population | Total |
|---|---|---|---|
| Mean | 98.1 ± 10.4 | 99.3 ± 10.8 | 98.9 ± 10.7 |
| BMI(kg/m²) | Men Population | Women Population | Total |
|---|---|---|---|
| Mean | 26.6 ± 4.9 | 28.9 ± 5.1 | 28.0 ± 5.2 |
| Systolic blood pressure(mm Hg) | Men Population | Women Population | Total |
|---|---|---|---|
| Mean | 139.9 ± 22.6 | 141.9 ± 23.9 | 141.2 ± 23.4 |
3 further baseline measures are reported on the registry.
Plan to share: Undecided
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University of Algiers